A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy.

The goals of this study are to learn:

* About the safety of MK-1045 and rituximab, and if people tolerate them when given together * If people who receive MK-1045 and rituximab have the cancer go away * If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)

Eligibility criteria

Qualifiers

Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.

Has radiographically measurable disease per the Lugano Response Criteria.

Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.

If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).

Disqualifiers

Has received prior systemic anticancer therapy or radiotherapy for FL.

Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.

Has FL that has transformed into a more aggressive type of lymphoma.

History or presence of clinically relevant central nervous system (CNS) diseases.

Trial design

Treatments tested in this trial

  • MK-1045
  • Rituximab
  • Rituximab biosimilar
  • Bendamustine
  • Cyclophosphamide
  • Vincristine
  • Prednisone
  • Prednisolone
  • Doxorubicin Hydrochloride

Treatment groups

960 Participants
are divided into 3 treatment groups

Sponsors and collaborators